Biomarker Guided Therapies in Stage A/B Heart Failure
1 other identifier
interventional
58
1 country
1
Brief Summary
Despite advances in cardiovascular care, the occurrence of heart failure (HF) is steadily increasing. The increase in HF rates poses enormous challenges, as once an individual becomes symptomatic or requires hospitalization with HF, the prognosis remains poor. Therefore, prevention of HF is essential. HF prevention is a critical issue as HF risk factors that include common medical conditions such as hypertension and diabetes are also increasing. However, not everyone with these risk factors develops HF. Using novel blood tests, the investigators propose to identify and treat subjects at higher HF risk to see if the investigators can stabilize or improve ultrasound measures known to be associated with HF risk. This study will enroll only Veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hypertension
Started Oct 2014
Longer than P75 for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedResults Posted
Study results publicly available
September 29, 2022
CompletedOctober 21, 2022
October 1, 2022
6.2 years
August 28, 2014
June 30, 2022
October 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cardiac Global Longitudinal Strain
Change in myocardial speckle tracked strain (global longitudinal strain) after 18 months (baseline vs. 18 months) of therapy with carvedilol or spironolactone or usual care. The myocardial global longitudinal strain was measured using echocardiography
18 months
Secondary Outcomes (3)
Change in NTproBNP (Biomarker)
18 months
Change in Pulse Wave Velocity
18 months
Change in Troponin T Measured Using a High Sensitivity Assay
18 months
Study Arms (3)
Carvedilol
ACTIVE COMPARATORApproximately 70 subjects will be randomized to carvedilol
Spironolactone
ACTIVE COMPARATORApproximately 70 subjects will be randomized to spironolactone
Usual care
OTHERApproximately 70 subjects will be randomized to usual care/ standard care by primary care providers
Interventions
Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure
Eligibility Criteria
You may qualify if:
- Age greater than 40 years
- One of the following in order to establish Stage A HF a. Hypertension b. Diabetes mellitus (controlled: defined as hemoglobin A1c less than 9%) c. Obesity (defined as BMI greater than 30 kg/m2) d. Metabolic syndrome (using the National Cholesterol Education Panel definition) e. Left ventricular hypertrophy (by ECG) f. Coronary or cerebrovascular arterial disease
- Troponin T measured by the high sensitivity assay of greater than 5ng/L
- Systolic BP 120-155 mmHg at primary care provider (PCP) visit and prerandomization visit (i.e., 2 separate confirmations of the same). If there is discordance between the PCP visit and pre-randomization the investigators will bring patient back to recheck his BP and use that as the tie breaker. Not orthostatic with measurements (defined as a fall in systolic BP greater than 20 mmHg when subjects assume an upright position). - Estimated 10-yr HF risk (based on Atherosclerosis Risk in Communities HF Lab model) greater than 5%
- Provides informed consent
You may not qualify if:
- Active Atrial fibrillation
- History of chest/ neck radiation
- High-risk chronic obstructive pulmonary disease (COPD) (GOLD classification 3-4 with greater than equal to 2 COPD exacerbations in the last 12 months)
- Known allergy to carvedilol or spironolactone
- Renal insufficiency with estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min
- Serum potassium greater than 5 meq/L
- Current use of carvedilol, spironolactone, any other beta-blockers or aldosterone antagonists
- Signs of clinical HF on initial examination (pulmonary rales/crackles, elevated jugular venous pulse with S3/S4 on auscultation)
- Left ventricular ejection fraction \<50% by echo
- Moderate or greater valve stenosis or regurgitation
- Hypertrophic cardiomyopathy
- Exposure to known cardiotoxic chemotherapy
- Poor echo image quality
- Right ventricular dysfunction more than mild
- Any valvular dysfunction that is more than mild
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Baylor College of Medicinecollaborator
Study Sites (1)
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vijay Nambi
- Organization
- Michael E DeBakey Veterans Affairs Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Vijay Nambi, MBBS
Michael E. DeBakey VA Medical Center, Houston, TX
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 3, 2014
Study Start
October 1, 2014
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
October 21, 2022
Results First Posted
September 29, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share