Non Invasive Assessment of Heart Failure

NCT04078425 | Unknown Early Phase 1 DMC

• 1 other identifier: Sharidi
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction.
2. 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. 3.To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy
4. 4.Vitamin D and its relation to cardiovascular disease and heart failure.

Conditions

Heart Failure

Keywords

Heart failure; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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'.

  6months

Study Arms (2)

HF with preserved EF

EXPERIMENTAL

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

Drug: Aldosterone Antagonists

HF with preserved EF recive eplernone

EXPERIMENTAL

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

Drug: Aldosterone Antagonists

Interventions

Aldosterone Antagonists 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; HF with preserved EF recive eplernone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosed heart failure dyspnea grade III or IV
• Heart failure with ejecton fraction ≤40

You may not qualify if:

• Acute coronary syndrome.
• Active infection
• Chronic kidney diseased patients
• Conn's disease

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Mineralocorticoid Receptor Antagonists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: September 6, 2019
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: January 9, 2020

Record last verified: 2020-01