Non Invasive Assessment of Heart Failure

NCT ID: NCT04078425

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-05-01

Brief Summary

1. To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction.

2. 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.

3. To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy

4. 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HF with preserved EF

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

Group Type: EXPERIMENTAL

Aldosterone Antagonists

Intervention Type: DRUG

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

HF with preserved EF recive eplernone

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

Group Type: EXPERIMENTAL

Aldosterone Antagonists

Intervention Type: DRUG

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

Interventions

Aldosterone Antagonists

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

salma hamdy mahmoud haridi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Sharidi

Identifier Type: -

Identifier Source: org_study_id