Clinical trial NCT01230307: Vitamin D Supplementation for Treatment of Heart Failure
Official title: D suppLementation In HearT FaiLure (DELIGHTFUL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Vitamin D
Systolic failure
Genomics
Biomarkers
Exercise
Quality of Life
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The central objective of this proposal is to establish that vitamin D supplementation in heart failure patients with low vitamin D levels will have improved outcomes compared to placebo. In addition the investigators will also evaluate the role of genetics in regard to vitamin D and heart failure. The investigators will be evaluating what is currently a novel approach of identifying patients with low vitamin D and treating this low vitamin D level. The investigators will be able to evaluate the importance of vitamin D supplementation in these patients and the role of genetics on our defined outcomes.

Detailed description: Primary Objective To determine how rapid vitamin D supplementation affects biomarkers and submaximal exercise capacity in systolic HF patients with low vitamin D status.

Working Hypothesis 1: HF patients when supplemented with vitamin D for 6 months will have lower measures of inflammation and extracellular-matrix remodeling compared with placebo.

Working Hypothesis 2: HF patients when supplemented with vitamin D for 6 months will have longer 6-minute walk length compared with placebo.

Secondary Objectives To establish a relationship between the CYP2R1 variant and surrogate markers in systolic HF patients.

Working Hypothesis 3: HF patients with the CYP2R1 G allele will have higher measures of inflammation and extracellular-matrix remodeling compared to AA subjects. This relationship will also be seen in subjects with the CYP2R1 TagSNP variants.

Working Hypothesis 4: HF patients with CYP2R1 variant alleles will have shorter 6-minute walk length compared to subjects without these variants.

To genotype HF subjects for the VDR variants and additional tag SNPs, to ascertain the relationship between VDR genetic variation and surrogate markers in systolic HF patients.

Working Hypothesis 5: HF patients with VDR variants will have greater measures of inflammation and extracellular-matrix remodeling compared to subjects without VDR variants.

Working Hypothesis 6: HF patients with VDR variants will have a shorter 6-minute walk length compared to subjects without these variants.

Eligibility criteria: Inclusion Criteria:

* HF patients with LV systolic dysfunction of ischemic or non-ischemic origin and an LVEF \<40% using nuclear ventriculography or echocardiography within the last 6 months.
* Attempts should have been made at optimizing medical therapy and the participant should be stable on these medications for at least 3 months.
* Patients with a 25(OH)D level between 10-25 ng/ml

Exclusion Criteria:

* Inability to give informed consent
* Patients with sarcoidosis or other granulomatous disease that can alter vitamin D metabolism
* Patients with primary valvular HF, hypertrophic cardiomyopathy, and drug-induced HF
* Renal dysfunction defined as serum creatinine \> 2.5 mg/dl
* Pregnant women
* Patients \<18 years of age
* Patients on vitamin D supplementation

Primary outcomes:
measure: Biomarkers
timeFrame: 6 months
Secondary outcomes:
measure: Exercise Capacity Measured by 6 Minute Walk Test
timeFrame: 6 months
measure: Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire
timeFrame: 6 months
measure: Vitamin D Genomics
timeFrame: Baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Barry E. Bleske, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References: