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Water Immersion in Chronic Stable Heart Failure (IMMERSE-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
water immersion
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age >18
  • Established diagnosis of heart failure with NTpro BNP >100

Exclusion Criteria:

  • Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest)
  • Severe fluid overload characterised as more than minimal pitting oedema of the ankles only
  • Presence of haemodynamically significant valvular heart disease in the opinion of the investigator
  • Haemoglobin <125 g/L
  • Weight >120 kilograms
  • Requiring long term oxygen supplementation in the community
  • Hospitalisation for any cause within the last 6 weeks, that in the opinion of the investigator would affect the patients wellbeing in this study
  • Unstable or severe stable angina that requires three or more antianginals
  • Patients known to have disease causing immunocompromise such as HIV infection or undergoing chemotherapy
  • Patients with active infection
  • Dialysis patients
  • Uncontrolled seizures; patients in whom the pool environment may trigger seizures, new diagnosis of epilepsy
  • Insulin treated diabetic patients with hypoglycaemic episodes in the last 3 months.
  • Pregnant women
  • Central venous lines which are not tunnelled and are exposed superficially.
  • Open access ports to lungs including tracheotomy sites
  • Ventilation tubes for ears
  • Nasogastric or gastrostomy tube in situ
  • Presence of colostomy, ileostomy or urostomy.
  • Presence of open, macerated, infected or non-intact skin or oedema with leakage of serous fluid.
  • Skin condition such as severe eczema or psoriasis
  • Any surgery or invasive devices fitted within the last 4 weeks
  • Any form of mobility impairment requiring mobility aids (e.g. stick or wheelchair) or rendering patient unable to perform gentle exercises, including recent injury or trauma
  • History of chlorine sensitivity
  • Urinary or faecal incontinence
  • Hydrophobia
  • Unable to give consent

Sites / Locations

  • Castle Hill Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

water immersion

Arm Description

patients with heart failure will be immersed to the neck for 15 minutes

Outcomes

Primary Outcome Measures

Cardiac output

Secondary Outcome Measures

Heart rate (beats/minute)
Blood pressure (mmHg)
systemic vascular resistance (dyn·s/cm5)
Stroke volume (millilitres)
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
BORG dyspnoea score (score between 1-10)
cardiac output (milliliters/minute)
N-terminal pro b-type natriuretic peptide (ng/L)
Left ventricular end systolic diameter (mm)
Left ventricular end diastolic diameters (mm)

Full Information

First Posted
October 13, 2016
Last Updated
June 17, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02949544
Brief Title
Water Immersion in Chronic Stable Heart Failure
Acronym
IMMERSE-HF
Official Title
Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2016 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
water immersion
Arm Type
Other
Arm Description
patients with heart failure will be immersed to the neck for 15 minutes
Intervention Type
Other
Intervention Name(s)
water immersion
Intervention Description
warm water immersion
Primary Outcome Measure Information:
Title
Cardiac output
Time Frame
15 minutes of water immersion
Secondary Outcome Measure Information:
Title
Heart rate (beats/minute)
Time Frame
15 minutes of water immersion
Title
Blood pressure (mmHg)
Time Frame
15 minutes of water immersion
Title
systemic vascular resistance (dyn·s/cm5)
Time Frame
15 minutes of water immersion
Title
Stroke volume (millilitres)
Time Frame
15 minutes of water immersion
Title
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
Time Frame
15 minutes of water immersion
Title
BORG dyspnoea score (score between 1-10)
Time Frame
15 minutes of water immersion
Title
cardiac output (milliliters/minute)
Time Frame
3 minutes of exercise in water
Title
N-terminal pro b-type natriuretic peptide (ng/L)
Time Frame
10 mins after water immersion
Title
Left ventricular end systolic diameter (mm)
Time Frame
15 minutes of water immersion
Title
Left ventricular end diastolic diameters (mm)
Time Frame
15 minutes of water immersion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >18 Established diagnosis of heart failure with NTpro BNP >100 Exclusion Criteria: Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest) Severe fluid overload characterised as more than minimal pitting oedema of the ankles only Presence of haemodynamically significant valvular heart disease in the opinion of the investigator Haemoglobin <125 g/L Weight >120 kilograms Requiring long term oxygen supplementation in the community Hospitalisation for any cause within the last 6 weeks, that in the opinion of the investigator would affect the patients wellbeing in this study Unstable or severe stable angina that requires three or more antianginals Patients known to have disease causing immunocompromise such as HIV infection or undergoing chemotherapy Patients with active infection Dialysis patients Uncontrolled seizures; patients in whom the pool environment may trigger seizures, new diagnosis of epilepsy Insulin treated diabetic patients with hypoglycaemic episodes in the last 3 months. Pregnant women Central venous lines which are not tunnelled and are exposed superficially. Open access ports to lungs including tracheotomy sites Ventilation tubes for ears Nasogastric or gastrostomy tube in situ Presence of colostomy, ileostomy or urostomy. Presence of open, macerated, infected or non-intact skin or oedema with leakage of serous fluid. Skin condition such as severe eczema or psoriasis Any surgery or invasive devices fitted within the last 4 weeks Any form of mobility impairment requiring mobility aids (e.g. stick or wheelchair) or rendering patient unable to perform gentle exercises, including recent injury or trauma History of chlorine sensitivity Urinary or faecal incontinence Hydrophobia Unable to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Clark
Organizational Affiliation
Castle Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU165JQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30267153
Citation
Shah P, Pellicori P, Kallvikbacka-Bennett A, Zhang J, Pan D, Clark AL. Warm water immersion in patients with chronic heart failure: a pilot study : Shah immerse: HF. Clin Res Cardiol. 2019 May;108(5):468-476. doi: 10.1007/s00392-018-1376-2. Epub 2018 Sep 28.
Results Reference
result
Links:
URL
https://link.springer.com/content/pdf/10.1007%2Fs00392-018-1376-2.pdf
Description
Full PDF Original Paper

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Water Immersion in Chronic Stable Heart Failure

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