Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 30 - 74 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | November 2015 |
Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients
This project seeks to reduce the disparity in hypertensive heart disease which exists for
African-Americans who have poorly controlled hypertension (HTN), also known as blood
pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject
population which stands to benefit tremendously from better BP control and a corresponding
decrease in heart damage. HTN occurs early in life and more often in African-Americans,
reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize
the emergency department (ED) for chronic BP management. Like cardiovascular disease,
vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to
play an important role in cardiovascular health. Vitamin D replacement in those who are
deficient has been thought to reduce the cardiovascular disease, especially if initiated
early before irreversible damage has occurred, but this has yet to be tested in a
prospective clinical trial. Accordingly, this proposal was designed to investigate the
relationship between vitamin D and cardiac damage (as identified on cardiac magnetic
resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive
patients without prior history of heart disease.
The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in
vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment,
which, if shown to be effective could improve the existing approach to a widely accessible,
cost-effective option.
African-Americans who have poorly controlled hypertension (HTN), also known as blood
pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject
population which stands to benefit tremendously from better BP control and a corresponding
decrease in heart damage. HTN occurs early in life and more often in African-Americans,
reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize
the emergency department (ED) for chronic BP management. Like cardiovascular disease,
vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to
play an important role in cardiovascular health. Vitamin D replacement in those who are
deficient has been thought to reduce the cardiovascular disease, especially if initiated
early before irreversible damage has occurred, but this has yet to be tested in a
prospective clinical trial. Accordingly, this proposal was designed to investigate the
relationship between vitamin D and cardiac damage (as identified on cardiac magnetic
resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive
patients without prior history of heart disease.
The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in
vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment,
which, if shown to be effective could improve the existing approach to a widely accessible,
cost-effective option.
Inclusion Criteria:
- Individuals with known HTN
- African-American race (self reported)
- Repeat SBP ≥ 160 mmHg within 1 hour of arrival
- Age 30-74 years
- Asymptomatic state (class I as defined by Goldman Specific Activity Scale)
Exclusion Criteria:
- Dyspnea (exertional, rest or nocturnal) or chest pain as a primary or secondary chief
complaint
- Prior history of HF, coronary artery disease, myocardial infarction, cardiomyopathy
(any), valvular heart disease (any) or renal failure with current, previous, or
planned future dialysis
- Acute illness or injury which necessitates hospital admission
- Acute alcohol or cocaine intoxication or history of chronic alcohol (determined using
the CAGE screening questions) or cocaine (self-reported) abuse
- Acute or decompensated psychiatric disorder or any underlying psychiatric disorder or
cognitive deficit which precludes effective on-going communication or ability to
follow-up as required
- Cancer (other than skin), HIV, or any other medical condition that might limit life
expectancy
- Hepatitis or liver enzyme (ALT, AST) elevations > 1.5x normal
- Planned move > 50 miles in the next 9 months
- History of kidney stones
- GFR <30
- Serum calcium > 10.5 mg/dl or known history of hypercalcemia
- History of or known primary hyperparathyroidism
- Sarcoidosis or other granulomatous disease
- Pregnant or planning to become pregnant
- Allergy or known hypersensitivity to gadolinium contrast
- Severe claustrophobia
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