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
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Echocardiography
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
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
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
Learn more about this trial
Non Invasive Assessment of Heart Failure
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