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Heart Failure With Reduced Ejection FractionGFRNCT03213821

Safety and Efficacy of High Protein Diet Versus GFR Based Protein Diet in Heart Failure Patients With Renal Insufficiency

A study testing protein intake in people with Heart Failure With Reduced Ejection Fraction and Renal Insufficiency, run by Rajaie Cardiovascular Medical and Research Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR) based protein intake in non-obese advanced HF patients will be assessed. In this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
protein intake
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Nov 2017to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced HF patients class III in New York Heart Association (NYHA) based on European Society of Cardiology (ESC) definition
  • Hand grip strength less than normal for age,
  • Age >18 years,
  • Glomerular filtration rate (GFR) 30-90,
  • BMI <30, muscle mass >2 standard deviations (SDs) below mean in individuals aged 18-39 y in the NHANES III cohort.

Who cannot join

  • Respiratory failure,
  • Ventilator dependence,
  • Dialysis treatment, and sepsis,
  • Open abdominal surgery within 6 weeks prior to enrolment,
  • Diseases or conditions that might change the calorie and macronutrients requirement.

About this study

Official title: Safety and Efficacy of High Protein Diet Versus Glomerular Filtration Rate (GFR) Based Protein Diet in Non-obese Advanced Heart Failure (HF) Patients With Renal Insufficiency: Randomized Controlled Trial

Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR) based protein intake in non-obese advanced HF patients will be assessed. In this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. Rehospitalization, quality of life, depression an inflammatory status are second endpoints.

Read the detailed description

Patient examinations:

Baseline data will be gathered on demographic and clinical characteristics, medical history, treatments and medications. Before initiating intervention, individuals will be assessed for anemia and 25 (OH) D2 and electrolytes status. Any insufficiency or imbalance will be corrected by drug therapy or supplementation. At baseline and at all visits, half or one month intervals, routine laboratory tests for heart failure patients (including Complete blood count (CBC), electrolytes status, glucose, albumin, cholesterol, triglyceride, blood urea nitrogen (BUN), C-reactive Protein (CRP),creatinine, uric acid, ferritin, 25 (OH) D, B-type natriuretic peptide (BNP), thyroid function, Prealbumin, urine analysis), appetite status and anthropometric measurements (weight, Hip and waist circumference) will be performed. At baseline and by the end of month 6, body composition, muscle mass, hand grip strength, Short Physical Performance Battery (SPPB), plasma lactate and interleukin 6 (IL-6), GFR, depression status and quality of life will be assessed. Follow up duration will be one year for measuring readmission and mortality rate. If a study participant did not attend a visit, a staff of randomized clinical trial (RCT) center will attempt to reach her/him, her/his designated friend or family member by phone call.

Being tested
protein intake
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • protein intakeOther

    For each participant, weighed food records of 3 consecutive days will be analyzed for estimation of calorie and macronutrient intake and dietary preferences. To make sure good compliance, diets will be developed regarding patient's dietary habits and preferences individually. High calorie (30-35 kcal/kg Ideal body weight) diets including 6-8 small meals will be formulated. Intervention group will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg IBW). Comparison group will receive protein based on GFR to preserve renal function. For older adults (>65 years) protein content of diet will be as recommended by the international study group to review dietary protein needs with aging (PROT-AGE). In subjects with lower intake of protein, carbohydrate will be substituted. Both group will receive low fat diet.

Study groups in NCT03213821
Study groupRoleWhat they receive
high protein intakeExperimentalStudy participants will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg Ideal Body Weight)
Receives: Other: protein intake
GFR based protein intakeActive comparatorStudy participants will receive GFR based protein diet to preserve renal function.
Receives: Other: protein intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline muscle mass at 6 months

    muscle mass will be assessed by Dual-Energy X-Ray Absorptiometry (DEXA)

    Measured: At baseline and after 6 months

Secondary outcomes (8)

  1. Change from baseline depression status at 6 months

    Cardiac Depression Scale (CDS) questionnaire

    Measured: At Baseline and after 6 months

  2. Change from baseline appetite status at 6 months

    Simplified Nutritional Appetite Questionnaire (SNAQ)

    Measured: At baseline, in each visit up to 6 months

  3. Change from baseline quality of life status at 6 months

    Kansas City Cardiomyopathy Questionnaire

    Measured: AT baseline and after 6 months

  4. Mortality rate

    Mortality occurrence

    Measured: Up to 1 year

  5. Rehospitalization

    Frequency of hospital admission in 1 year

    Measured: Number of hospital admission will be recorded from date of intervention initiation until 1 year

  6. Change from baseline kidney function at 6 months

    Glomerular filtration rate (GFR) (WIZARD® Automatic Gamma Counter) will be performed

    Measured: At baseline and after 6 months

  7. Change from baseline handgrip strength at 6 months

    Handgrip strength will be measured using hand grip dynamometer

    Measured: At baseline and after 6 months

  8. Change from baseline physical performance at 6 months

    SPPB score will be measured for physical performance assessment which includes: gait speed (timed 4-metre walk), sit-to-stand time (timed test of five chair rises), and standing balance (side-by-side stand, tandem and semi-tandem positions)

    Measured: At baseline and after 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start1 Nov 2017 (estimated)
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study design A randomized, parallel-arm, controlled pilot study is designed. Sample size is determined 50 participants per treatment arm using the stepped rules of thumb, with standardized effect sizes of 0.1 or less and power 80% for main trial (n=100). After baseline assessments, balanced permuted block method will be used for randomization. Concealment of the randomization sequence will be performed by the RCT center of Rajaie Cardiovascular, Medical and Research Center. Intervention will be according to the randomization sequence.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03213821
Sponsor's protocol ID
96001
Acronym
GFR
Status last verified
Jul 2017
First submitted
8 May 2017
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be kept confidential.

Questions about this trial

What is this clinical trial studying?

A study testing protein intake in people with Heart Failure With Reduced Ejection Fraction and Renal Insufficiency, run by Rajaie Cardiovascular Medical and Research Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline muscle mass at 6 months (time frame: At baseline and after 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03213821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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