RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

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ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / DR. KULDEEP SHETTY
S/o P SUBBANNA SHETTY
# 3/A, UPSTAIRS, 2ND CROSS, 2ND MAIN, JAYANAGAR, MYSORE.
2. / NAME OF THE INSTITUTION / MYSORE MEDICAL COLLEGE & RESEARCH INSTITUTE, MYSORE
3. / COURSE OF STUDY AND SUBJECT / M.D. (GENERAL MEDICINE)
4. / DATE OF ADMISSION TO COURSE / 3RD JULY 2010
5. / TITLE OF TOPIC / “STUDY OF N-TERMINAL PRO BNP LEVELS IN HEART FAILURE"

6. BRIEF RESUME OF THE INTENDED WORK

6.1 Need for the Study

Congestive cardiac failure is the leading cause of morbidity and mortality throughout the world and also the leading cause of hospitalization in adults over 65 years of age. In addition , it is the only cardiovascular disorder that continues to increase in both incidence and prevalence, and as aging population is increasing, it is expected that the prevalence of this disease will continue to rise.(1) An early and correct diagnosis is crucial in heart failure therapy to reduce the mortality and the number of hospital readmissions. And also, overtreatment should be avoided due to the cost and side effects associated with the medications. Echocardiography is routinely performed to establish the diagnosis of impaired left ventricular systolic function, but this method requires expensive equipment and skilled operators and is not always readily available. During the past few years B-type natriuretic peptide(BNP) and N-terminal fragment of its prohormone (NT pro BNP) have emerged as promising markers of ventricular dysfunction and heart failure, and biochemical tests for rapid measurement of these substances have been developed.(2) Strong inverse correlations have been reported between survival and plasma levels of BNP.(3) Phsyical findings in heart failure are not sensitive for detection of fluid retention, and the availability of serum BNP level greatly improves the diagnostic accuracy.(4)

6.2 Review of Literature

N-Terminal proBNP belongs to a family of natriuretic peptides primarily secreted from heart in response to an increased wall tension. Both BNP and NT pro BNP are relatively sensitive markers for presence of heart failure.(5) The release of BNP into circulation is directly proportional to the ventricular expansion and volume overload of the ventricles and therefore reflects the decompensated state of the ventricles.(6) NT proBNP is more stable and has a slower plasma clearance than BNP making it a more suitable peptide for assays.(7)

However it is important to recognize that natriuretic peptide levels increase with age, renal impairment. It can be falsely low with obesity,and may normalize after appropriate treatment.

As per The N-Terminal proBNP Investigation of dyspnea in the Emergency Department (PRIDE) Study, NT-proBNP at cutpoints of >450pg/ml for patients <50 years of age and >900pg/ml for patients >50 years of age were highly sensitive and specific for the diagnosis of acute CHF (p<0.001). (8)

As per the university of Iowa(UHIC), Department of Pathology, the levels of NT pro BNP, in pg/ml, for chronic heart failure patients are

NYHA 1 NYHA 2 NYHA 3 NYHA 4

Mean 1015 1666 3029 3465

5th percentile 33 103 126 148

95th percentile 3410 6567 10449 12188 (9)

6.3 Objectives of the Study

To find correlation between N terminal pro BNP levels in heart failure and confirmation with other investigation modalities.

7. MATERIALS AND METHODS

7.1 Source of Data

Patients admitted in K.R. Hospital during the study period from November 2010 to May 2013.

7.2 Method of Collecting Data:

Sample size: Minimum of 50 patients presenting with features of heart failure.

Sampling method: Simple random sampling.

INCLUSION CRITERIA

Patients presenting with clinical features of heart failure.

EXCLUSION CRITERIA

1. Patients in renal failure

Data will be collected using a pretested proforma meeting the objectives of the study. Detailed history, physical examination and necessary investigations will be undertaken. The purpose of the study will be explained to the patient and informed consent will be taken.

The Analysis of data will be done using appropriate statistical methods.Ethical committee clearance will be taken.

7.3 Does the study require any investigation to be conducted on patients? If so, please describe briefly.

Investigations:

Routine investigations:

1.  N-Terminal proBNP levels

2.  2D-Echocardiography

3.  Electrocardiography in 12 leads

4.  Troponin-T (if needed)

5.  CK-MB (if needed)

6.  Hb%,

7.  TC

8.  ESR

9.  RBS

10. B. Urea

11. Serum Creatinine

12. Chest X Ray

13. Lipid profile

14. Thyroid profile

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes (copy enclosed)

8. List of references

1.  O’Donoghue M, Januzzi JL. Jr., N-terminal proBNP; a novel biomarker for the diagnosis, risk stratification and management of congestive heart failure, Expert rev cardiovasc Ther. 2005; 487-96.

2.  Torbjorn Omland, N-Terminal ProBNP:Marker of Systolic Dysfunction or Nonspecific Indicator of Cardiac Diseases, L.Januzzi, Carlos A. Camargo, Saif Anwaruddin et al, HeartDrug 2003;3:122-24

3.  Douglas L Mann, Management of Heart failure patients with reduced ejection fraction. Brawnwald’s Cardiology, 8th Edn. Chapter 25, page 613-15

4.  Diagnosis and Management of Heart Failure,Hurst’s The Heart,11th edition, Chapter 25

5.  Douglas L Mann, Section 4-Disorders of Heart, Heart failure and Cor Pulmonale, Harrison’s Principles of internal medicine 17th Edition, Page 1417.

6.  Hans Kemperman, Mery van den Berg, Hans Kirkels and Nicolaas de Jonge: BNP and N-Terminal proBNP in patients with End-Stage Heart Failure Supported by a Left Ventricular Assist Device, Biochemical and Molecular Basis of Paediatric Disease, 4th

Edition, 1670-72.

7.  V. Kirk, M. Bay, J. Parner et al, N- Terminal proBNP and mortality in hospitalized patients with heart failure and preserved vs reduced systolic function: data from prospective Copenhagen Hospital Heart Failure Study(CHHF), Oxford Journals, European Journals of Heart Failure, Volume 6, Issue 3, page 335-41.

8.  James L Januzzi, Carlos A Camargo, Saif Anwaruddin et al,The N-Terminal Pro-BNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study, American Journal of Cardiology Vol. 95, 2005.

9.  Laboratory Services Hand Book, Department of Pathology, University of Iowa,www.medicine.uiowa.edu.


9. Signature of the Candidate :

(Dr. Kuldeep Shetty)

10. Remarks of the Guide :

11. NAME AND DESIGNATION OF :

(in block letters)

11.1 Guide : DR. LAXME GOWDA, MD

Assistant Professor,

Department of Medicine,

Mysore Medical College &

Research Institute, Mysore.

11.2 Signature :

11.3 Head of the Department : DR. H VASUDEVA NAIK, MD

Professor and Head,

Department of Medicine,

Mysore Medical College &

Research Institute, Mysore.

11.4 Signature :

12. Remarks :

12.1 Remarks of the Dean and Director :

12.2 Signature :