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Non Invasive Assessment of Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Aldosterone Antagonists
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Echocardiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. clinical diagnosed heart failure dyspnea grade III or IV
  2. Heart failure with ejecton fraction ≤40

Exclusion Criteria:

  1. Acute coronary syndrome.
  2. Active infection
  3. Chronic kidney diseased patients
  4. Conn's disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HF with preserved EF

    HF with preserved EF recive eplernone

    Arm Description

    50patients of heart failure with preserved ejection fration will receive anti.failure treatment(lanoxin,beta blocker,diuretics) for one month with follow up echocardiography before and after

    50 patients with heart failure with preserved ejection frationnwill receive traditional anti-failure treatment in addition to aldosterone antagonist (Eplernone) with follow up echocardiography and aldosterone level before and after

    Outcomes

    Primary Outcome Measures

    Role of aldosterone antagonist in treatment of heart failure
    To evaluate the effect of aldosterone antagonist on exercise capacity of patients with established and symptomatic HFPEF and to evaluate the effect of aldosterone antagonist on diastolic function (the lateral mitral annular doppler tissue imaging measurments were used for assessment of early diastolic relaxation velocity (E'),ameasure of ventricular relaxation and for calculation of E\E'.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2019
    Last Updated
    January 7, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04078425
    Brief Title
    Non Invasive Assessment of Heart Failure
    Official Title
    Non Invasive Assessment of Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction. Portray the health profile of heart failure patients admitted in internal medicine department either heart failure with reduced ejection fraction or heart failure with preserved ejection fraction. To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy Vitamin D and its relation to cardiovascular disease and heart failure.
    Detailed Description
    Heart failure (HF) is a growing epidemic related to significant morbidity and mortality. The prevalence of the disease continuously increases due to the ageing population and success in treating cardiovascular diseases that often precede HF. Lifetime risk of HF is still high with 20-45% and strongly age-dependent . Structural or functional alterations in the heart lead to reduced cardiac output and rising intracardiac pressures. The resulting HF syndrome comprises typical symptoms such as dyspnoea, ankle swelling and fatigue . Heart failure is classified into right sided heart failure and left sided heart failure,the later one is classified to HF with reduced EF (HFrEF) involving patients with an EF< 40% and heart failure with preserved ejection fraction (HFpEF) The proportion of HFpEF seems to be slightly lower than that of HFrEF . For patients presenting with breathlessness, there is a need for a reliable biomarker for the early diagnosis of heart failure. Similarly, there is also a need for better monitoring of patients receiving treatment for heart failure. Non-invasive means such as a biomarker have therefore become useful. There are many potential biomarkers for heart failure, the investigators will discuss the biomarkers that are available for clinical use in patients with heart failure to further assess prognosis and possibly direct HF therapy. There is evidence that aldosterone antagonists can oppose the effect of aldosterone in promoting cardiac fibrosis.Furthermore, elevated levels of cardiac aldosterone have been demonstrated in a rat model of hypertensive diastolic HF, and use of the aldosterone antagonist, eplerenone, was associated with attenuation of left ventricular diastolic dysfunction and reduction in left ventricular mass and fibrosis in this model.Thus, aldosterone antagonism has the potential to be a beneficial therapeutic strategy in patients with HFpEF. Vitamin D has the potential to improve the symptoms ofheart failure (HF) and to modulate the disease,Vitamin D supplementation can reduce blood pressure and improve skeletal muscle function and strength. Animal studies suggest that active vitamin D down-regulates the renin-angiotensin-aldosterone system (RAAS), reduces retention of salt and water, and reduces myocardial hypertrophy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HF with preserved EF
    Arm Type
    Experimental
    Arm Description
    50patients of heart failure with preserved ejection fration will receive anti.failure treatment(lanoxin,beta blocker,diuretics) for one month with follow up echocardiography before and after
    Arm Title
    HF with preserved EF recive eplernone
    Arm Type
    Experimental
    Arm Description
    50 patients with heart failure with preserved ejection frationnwill receive traditional anti-failure treatment in addition to aldosterone antagonist (Eplernone) with follow up echocardiography and aldosterone level before and after
    Intervention Type
    Drug
    Intervention Name(s)
    Aldosterone Antagonists
    Intervention Description
    aldosterone antagonist will be applied to patients of heart failure with preserved ejection fraction, level of the drug will be sampled before administration of the drug and follow up will be sampled after one month
    Primary Outcome Measure Information:
    Title
    Role of aldosterone antagonist in treatment of heart failure
    Description
    To evaluate the effect of aldosterone antagonist on exercise capacity of patients with established and symptomatic HFPEF and to evaluate the effect of aldosterone antagonist on diastolic function (the lateral mitral annular doppler tissue imaging measurments were used for assessment of early diastolic relaxation velocity (E'),ameasure of ventricular relaxation and for calculation of E\E'.
    Time Frame
    6months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosed heart failure dyspnea grade III or IV Heart failure with ejecton fraction ≤40 Exclusion Criteria: Acute coronary syndrome. Active infection Chronic kidney diseased patients Conn's disease

    12. IPD Sharing Statement

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    Non Invasive Assessment of Heart Failure

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